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 | Location  | City | Job Type | Job Title | Category | Status |  |
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| IL | Morton Grove | Temporary | Clinical Quality Assurance | Clinical | Open | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Manager, Quality Operations
Position Description
- The management of the Label Control area and personnel to ensure that labeling material needed for filling and packaging are stored, issued and returned per SOPs.
- The management of the Incoming Inspection area and personnel in inspecting and releasing incoming materials, including but not limited to Raw Materials, Components, Printed Material and Returned Goods.
- The management of the In-process Quality Assurance area and personnel in performing in-process checks during compounding, filling and packaging.
- The management of the Batch release area and personnel involved in review and release of product to commerce and placing product on hold.
Position Responsibilities
- Ensures the Label Control Clerk is performing duties which are compliant to SOPs and cGMPs including but not limited to storing, issuing and return of printed material.
- Coordinates with Regulatory Affairs to ensure current labeling revisions are correct and when current revisions are depleted from inventory.
- Coordinates with Material Management Department to ensure the labeling material is available for Filling and Packaging to produce product.
- Ensures Inspection activities being performed by the Incoming Inspector are compliant with SOPs and cGMPs including but not limited to Inspection, Sampling and Release of Raw Materials, Printed Material, Components and Returned Goods.
- Performs review of Manufacturer’s COA to the QCTR and performs other Incoming Inspection duties within the department in order to meet deadlines.
- Manage the QA In-process department to ensure scheduling and planning needs are met.
- Audit the daily activities in the manufacturing area to ensure compliance with cGMPs and SOPs.
- Work closely with manufacturing, packaging and Maintenance departments to assure quality production results and to ensure compliance to SOPs and cGMPs.
- Manages the Batch Release Department in the review of batch documentation in order to release Finished Product into commercial inventory.
- Responsible for the update of departmental SOP’s and reviews of batch records.
- Reviews documentation for accuracy and compliance to Good Documentation Practices.
- Train new employees and review job performance of current employees.
- Ensures employees are properly trained prior to them performing their job responsibilities.
- Responsible to perform review of SOPs, Packaging Component Specifications and Raw Material Specifications every two years
Responsible for investigating or aiding in the investigation of deviations that occur within the department or that are related to incoming material. - Responsible for responding to Internal Audit observations
- Other duties as assigned by Quality Management
Position Requirements - College Degree in Life Science or Engineering.
- 5-10 years of Management experience in Pharmaceutical Industry.
- Ability to work well with other departments.
- Excellent Communication Skills.
- Computer literate with working knowledge of Microsoft Office and Microsoft Access.
- Strong Time Management and multi-tasking abilities.
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | IL | Round Lake | Permanent | Clinical Quality Assurance | Clinical | Open | | | Delta Scientific is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Product Surveillance Nurse
Position Description
- This position is responsible for managing in-depth complaint investigations, with expert product knowledge. This role is responsible for report submissions to regulatory bodies and providing information to Baxter business units for decision-making purposes. This position is a subject matter expert in the team and will train and mentor other Product Surveillance Quality Associates. Infusion pumps and dialysis products.Both U.S. and global review.
Position Responsibilities
- Process high-risk (Death/Serious Injury) complaints without supervision
- Determine reportability of a complaint and submit associated Medwatch reports within 30 days per regulations
- Lead the investigation, including developing investigation plan, defining members of investigation team and their roles and responsibilities, plan on-site visits, follow-up communication with internal and external customers
- Travel to customer sites to obtain information pertinent to the investigation, including sample, clinical and engineering information
- Guide Specialists leading high-risk investigations, review Medical Device Reports associated with death and serious injury
- Produce and maintain annual base line reports, Alternative Summary Reports and 24-Month Reports as required by the Medical Device Reporting regulation Perform trend reporting and escalate results to appropriate business units for consideration of necessary actions
- Represent Product Surveillance on Product Improvement Teams, as well as CAPA.
Position Requirements - Expert knowledge of the FDA Quality System and Medical Device Reporting regulations (21 CFR 803, 806, 820 and 211.)
- Understanding of regulations governing markets outside the U.S. Expert understanding of the product’s intended use and manufacturing process of assigned products
- Bachelor’s degree in Nursing or Medical Technology is required
- 7 years experience, which should include Product Surveillance, direct clinical/medical experience, or relevant product/technical expertise
- Experience managing CAPA is preferred
- 5% travel
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| | | NJ | Kinnelon | Temporary | Clinical Quality Assurance | Clinical | Open | | | The QA Consultant will provide guidance and support for the development, direction, execution and compliance of the Company’s Corporate Quality Assurance programs to comply with all appropriate quality regulations. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- The QA Consultant will provide guidance and support for the development, direction, execution and compliance of the Company’s Corporate Quality Assurance programs to comply with all appropriate quality regulations.
- The position is responsible for advising the Company on the management and/or performance of all GMP, GLP, GCP (GXP) QA functions.
Position Responsibilities - Support and coordinate preparation for, and assist with, the management of regulatory agency inspections.
- Provide updates and recommendations to upper management on compliance or quality risks and concerns.
- Assist with the development, editing and implementation of Quality Assurance SOPs, Forms and GMP Documentation to support GMP Manufacturing and product release.
- Support the development and management of a GMP external audit program to qualify contractors. Perform qualification audits of GMP/GLP facilities as required. Develop, implement and maintain the contractor audit/visit schedule. Generate audit/visit agendas and reports to summarize findings, evaluate audit responses and follow-up closure.
- Perform final approval of master and production records for finished drug product, and packaging batch records, including evaluation of deviations and incidents for possible impact on product quality. Release drug product, including release certificates and labeling.
- Perform or manage QA review and approve of all the Company’s GMP/GLP SOPs
- Work closely with the Chief Scientific Officer and VP of Regulatory Affairs in selecting, evaluation, establishing and maintaining compliant contract facilities.
- Conduct internal audits and manage internal audit program to assure GMP’s/GLP’s relevant laws, guidelines, strategies and Company SOPs and procedure are adhered to.
- Support the development of GMP/GLP training programs and provide introduction and current training to Company employees on a periodic and ongoing basis.
- Manage and coordinate QA consultant visits and audits – providing corrective actions and improve quality systems where necessary.
- Liaise between Company and Quality Control/Assurance at contractor facilities.
- Satisfactorily resolve quality and compliance issues with contract facilities on an ongoing basis.
- Provide Quality Assurance support to Regulatory Affairs Consultant with regard to manufacturing issues and quality issues related to regulatory submissions.
- Keep current on governmental regulatory requirements related to quality assurance issues involving clinical and commercial manufacturing and control that relates to the production of API’s, biopharmaceutical and drug products.
- Travel up to 25%, as required. Some international travel may be required
- Assure that all systems, procedures and practices of the document control function at vendors is adequately controlled including (where applicable):
- Control of electronic version of documents
- Electronic document control and security systems, including validation as necessary
- Control of hard copies of documents
- Assure that proper filing and storage practices are in place with the most current revisions of documents are available to the end users. Assure document revision history’s are maintained and are available for regulatory agency review.
- Provide current documentation to support regulatory filings as necessary
- Provide adequate support for regulatory agency inspections as required.
- Use databases to track, trend, report QA activities and identify improvements
Position Requirements - Associate Education: BA/BS in Biology, Chemistry or other relevant scientific or technical discipline Advanced Degree preferred
- Minimum 5 years in Quality Assurance.
- Minimum 5 years in a Pharmaceutical/Biopharmaceutical environment.
- FDA inspection experience.
- Knowledge of US, EU, ICH Regulations, Guidelines and Requirements. Knowledge of GCP requirements in conducting clinical trials.
- Demonstrated Supervisory and Management experience.
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| | | We currently do not have any other open positions that match your criteria, but new positions could become available at any time. Below is a sampling of the type of positions that we have had available in the past that match your search criteria. | | |
| | | CA | South San Francisco | Temporary | Clinical Quality Assurance | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together. Come be a part of our success story!
Job Title
Position Description
- The Associate in ExQ Collaborations reports to the Manager of the group and is accountable for providing support in the resolution of any quality related issues associated with the supply of products to its commercial business partners.
Position Responsibilities
- Support the resolution of a wide range of problems received from partners associated with the supply of product as defined in accordance with the effective Quality Agreement.
- Provide partners with the highest customer support in the resolution of all quality related queries relevant to the products supplied.
- Build strong relationships with external and internal stakeholders in the uninterrupted supply of product to business partners.
- Facilitate business process improvement initiatives as assigned so that ExQ Collaborations successfully achieves and maintains its Class A status.
- Translate partner requirements, as stated in quality agreements, into GMP controlled documents (e.g., Standard Records, Manufacturing Tickets, SOPs).
- Facilitate partner notification of GMP changes to product manufacturing and testing processes. Track notifications as they occur to ensure products manufactured with newer processes are not supplied to partners until the partners have received approval from the relevant regulatory authorities for a specific change.
- Coordinate partner complaints and ensure timeliness of investigation and closure with complaint management department.
- Coordinate all relevant activities required with Product Quality group to satisfy the partner’s Annual Product Review requirements.
- Assist in the preparation and execution of partner visits, audits, and partner territory regulatory agency inspections of relevant contractors.
- Represent ExQ Collaborations on assigned projects.
- Support the Manager of ExQ Collaborations in all matters as assigned.
Position Requirements - Computer proficiency, understanding of cGMPs for biopharmaceutical, must be collaborative, a strong bias for results that benefits both company and its business partner, must be able to thrive in a dynamic work environment of while balancing multiple projects.
- B.S. in a scientific discipline or equivalent work experience
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | CA | South San Francisco | Temporary | Clinical Quality Assurance | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Duties Perform sampling and testing of routine and non-routine process water and compressed gases.
- Perform environmental monitoring in various manufacturing controlled areas.
- Review data and assess against established acceptance criteria.
- Perform technical review of peer-generated data for basic methods.
- Perform LIMS, Labware entry and validation of water and environmental monitoring data.
- Identify discrepancies, participate in quality investigations and CAPA (corrective actions preventive actions) initiatives as needed. Perform trouble shooting, equipment qualification / maintenance of basic lab equipment.
- Prepare and maintain standards, controls, stocks, and cultures per established procedures.
- Support the maintenance and compliance of operational areas. Assure and apply GMP throughout operations.
- Coordinate with customers to support operational activities. Support internal and external audits.
- Actively participate in group and project teamwork, validation protocols and process improvements.
- Assist in training of new personnel.
- Draft protocols and reports under supervision.
- Meet scheduled performance of 95% on time.
Position Requirements - Ability to work well with others in a positive and collaborative manner.
- Computer literacy and experience working in a cGMP environment are preferred, but not required.
- Basic knowledge of scientific theories, principles and techniques used in analytical or biological test procedures.
- Able to carry 20-25 lbs and multi-task.
- Able to write clearly and effectively.
- Good verbal communication skills.
- Able to exercise sound judgment, reasoning and
problem solving. - Capable of completing assigned responsibilities and keeping manager informed of status.
- Education BS/BA in Microbiology, Biochemistry, Chemistry or related field
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
|
| | | CA | South San Francisco | Temporary | Clinical Quality Assurance | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Duties Review executed batch records, assess CMO deviations and investigations.
- Review executed versus approved master batch records for compliance to clinical trial protocols, regulatory filings, product requirements and cGMP compliance.
- Ensure that manufacture and testing of clinical supplies of sponsor's small molecule GMP intermediate (including cytotoxic drugs and/or linkers used in the antibody-drug conjugate program), API and drug product at contract manufacturing organizations (CMOs) is conducted in accordance with cGMP.
Position Requirements - At least 4 years direct experience in quality assurance, including batch record review, for pharmaceutical operations is required.
- Demonstrated working knowledge of Quality Assurance and manufacturing principles.
- Education BS/BA in a relevant scientific discipline or equivalent and demonstrated working knowledge of Quality Assurance and manufacturing principles.
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
|
| | | CA | South San Francisco | Temporary | Clinical Quality Assurance | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Responsible for compliance support activities for GMP testing laboratory, including coordinating equipment qualification and preventative maintenance activities and to ensure that equipment and systems remain in a validated and/or maintained state and provide support for equipment change orders and various administrative support duties.
Position Requirements - Knowledge in GMP and validation lifecycle. Experience with MS Excel, Visio, and File Maker Pro a plus.
- Must demonstrate ability to multi-task and work in fast pace environment.
- Excellent communication skills and can work independently.
- Education B.S. in physical or life sciences or engineering
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
|
| | | NJ | Fort Lee | Temporary | Clinical Quality Assurance | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together. Come be a part of our success story! Job Title- GCP- Internal Audit Manager
Position Description- The GCP Internal Audit Manager should be well versed in developing an internal audit program as well as comfortable in conducting external clinical audits at CRO’s. The selected consultant will need to travel at least 30% to CRO sites.
Position Requirements- BS/BA degree plus 10 years direct pharmaceutical clinical research experience/quality assurance experience in GCP
- Ability to build and lead an internal audit team
- Travel 30%
Benefits- Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
|
| | | NJ | New Brunswick | Temporary | Clinical Quality Assurance | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together. Come be a part of our success story!
Job Title
Position Description
- Quality Assurance Specialist with combination of education, experience, and training to effectively review and approve Commissioning, Qualification, and Validation (CQV) lifecycle deliverables associated with facilities, utilities, equipment, instruments, and computerized systems supporting Investigational Medicinal Products and Clinical Supply Operations.
Position Requirements - Solid understanding of the CQV requirements pertaining to GMP regulated operations. Demonstrated knowledge and experience in application of industry accepted CQV standards and guidelines (ICH, ISPE, ISO, ATSM, PDA, GAMP 21 CFR 211, 21 CFR 11 etc.)
- Strength in the qualification of analytical and microbiological laboratory instrumentation and equipment, computerized and non-computerized.
- Provide support to the Functional Area analytical instrument/ equipment qualification activities
- Review and approve pre-executed and post-executed Installation/Operational/Performance Qualification Protocols
- Review Instrument and equipment related Work Instructions for quality and compliance issues
- Familiarity with instruments, equipment and utilities supporting analytical labotaory operations (i.e. High Pressure Liquid Chromatograph, Gas Chromatograph, Atomic Absorption Spectroscopy, Ultra Violet Spectroscopy, Karl Fisher, Freezers, Refrigerators, Incubators, Water Systems, HVAC Units)
- Conduct review of documentation for compliance to and FDA regulated policies
- Review change control documentation for applicability to standards
- Communicate any identified or potential problems to supervisor
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | PA | Exton | Temporary | Clinical Quality Assurance | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Conduct under supervision a series of detailed GCP audits of Phase I – III domestic and international clinical research trials to assure compliance with all applicable government regulations, federal guidelines, company standard operating procedures, and industry standards. Audits will be performed on external investigator sites, vendors/CROs, trial master files (TMFs), data/CRFs, study reports for clinical trials conducted
Position Requirements - BA/BS degree in biological sciences, nursing or related discipline, or equivalent experience required with a minimum of 2-3 years working experience as a clinical quality assurance auditor
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | PA | Exton | Permanent | Clinical Quality Assurance | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together. Come be a part of our success story!
Job Title
Position Description
- Independently conduct a series of detailed GCP audits of Phase I – III domestic and international clinical research trials and/or GCP-related systems and processes to assure compliance with all applicable government regulations, federal guidelines, company standard operating procedures, and industry standards
Position Responsibilities - Audits will be performed on external investigator sites, vendors/CROs, trial master files (TMFs), data/CRFs, study reports, and GCP-related systems/processes for clinical trials conducted
Position Requirements - BS/BA degree in biological sciences, nursing or related discipline, or equivalent experience required
- Strong knowledge of government regulations, guidelines and standards for investigation of new pharmaceutical products is required
- Experience in QA audits of Clinical Investigators
- Experience in QA audits of Clinical documents associated with clinical trials
- Experience in system/process audits
- Experience in development of SOPs
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | WA | Seattle | Temporary | Clinical Quality Assurance | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Product Quality Leader II
Position Description
- With general supervision, is responsible and accountable for the development and implementation of the Qualify aspects of the Global Operations Plan.
- Is also the technical expert for the assigned development product(s).
Position Responsibilities - Lead technical investigations related to determination of root cause and product impact of manufacturing excursions.
- Design analytical approaches to technical investigations relevant to operations, and provide interpretation of results in oral and written formats.
- Must assimilate and disseminate information from diverse work streams to ensure product quality is achieved consistently and efficiently.
- Provides scientific and technical advice for the development of site policies, site practices and compliance for product integration with operations.
- May be involved in providing scientific advice and coordination for product transfer, as well as research and development of new and existing products to ensure alignment with operations.
- Provide technical support for product manufacturing, testing, regulatory submissions, inspections, project management, development and championing of regulatory strategies, and interaction with corporate product operations and quality teams.
- Responsible for communicating product and testing related issues to and from site Quality groups and corporate teams.
Position Requirements - Degree in Analytical Science, Chemistry, Engineering, Biochemical Engineering, Biotechnology, or Life Sciences.
- Technical experience within biotech industry.
- Experience with process development, manufacturing, or quality functions.
- Strong project management skills and able to handle multiple projects simultaneously
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holidayand Vacation Pay
- Relocation Assistance
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